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Physiologically-based Modeling Supports Drug Development Decisions, Regulatory Interactions and Drug Labeling

Today’s powerful and actively evolving computational tools enable sponsors and regulators to understand potential drug characteristics and subject responses earlier in development, with greater certainty. Model-based approaches support timely, confident decisions across the development and regulatory lifecycle by gathering disparate sources of information about a drug, its competitors, target disease and patients into a mathematical knowledge framework.

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OTHER WHITEPAPERS

Using High Throughput SPR to Explore the Full Kinetic and Epitope Diversity of Large Antibody Libraries

whitePaper | February 24, 2023

A new way of thinking and working has evolved for the discovery of therapeutic antibodies. Until recently, large numbers of antibodies were generated, only for a relatively small fraction to be sampled and engineered for further lead generation.

Overcoming technical challenges in cell-based high throughput screens

whitePaper | November 11, 2022

Tremendous technological advancements in automated biotechnology and combinatorial chemistry have led to the widespread implementation of high throughput screening (HTS) for drug discovery since the early 1990s.

Access to medicinal products

whitePaper | January 3, 2022

There are many factors that can prevent a patient from being able to obtain the medicine they need, ranging from selective marketing decisions by companies to products being too expensive or pharmacy stock-outs

Manufacturing High-Quality Capsule Products for Pharmaceutical and Nutraceutical Applications

whitePaper | October 25, 2022

To confirm the suitability of empty hard capsules for use in the application of quality-by-design (QbD) in the development and manufacturing of finished pharmaceutical products, the quality target product profile (QTPP) defined by eight critical quality attributes (CQA’s) was examined.

Shining a Light on Lipid Nanoparticle Characterization

whitePaper | October 3, 2022

Next-Generation Synthetic Biology Workflow Platform Codex DNA’s BioXp 9600 system is a next-generation high throughput platform intended for automated synthesis of gene fragments and clones from digital sequences.

Seize the digital momentum

whitePaper | January 23, 2023

Investments in biopharmaceutical (biopharma) research and development (R&D) continue to fuel innovation and shape the future of health. However, this year’s analysis demonstrates that despite impressive examples of innovative products the step-change in improved productivity seen in 2021 has not continued.